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FDA NDA · NDA209090

CHILDRENS XYZAL ALLERGY

levocetirizine dihydrochloride

Sponsor: CHATTEM SANOFI

APPLICATION
NDA209090
TYPE
NDA
ORIGINAL APPROVAL
2017-01-31
LATEST ACTION
2026-03-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

XYZAL ALLERGY 24HR · ReferenceOver-the-counter
LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML · SOLUTION · ORAL

Approval history

2026-03-05Labeling · Supplement 7 · standard — Letter ↗AP
2025-07-22Manufacturing (CMC) · Supplement 6 — Label ↗AP
2022-10-28Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2022-07-13Manufacturing (CMC) · Supplement 3 — Label ↗AP
2020-11-10Labeling · Supplement 2 · standard — Letter ↗AP
2017-01-31Type 8 - Partial Rx to OTC Switch · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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